1. Field of the Invention
This invention relates generally to temperature monitoring devices.
2. Prior Art
Some temperature sensitive products must be shipped and stored within strict temperature limits. For example, according to FDA (Food and Drug Administration) regulations, freshly drawn whole blood must be cooled from body temperature down to a storage temperature range of between 1-6 degrees Celsius within 6 hours. The temperature range during shipment can be between 1-10 degrees Celsius. In addition, the blood temperature must decline in a continuously downward trend when cooling toward the shipping and storage temperature ranges. Many other pharmaceutical products also have temperature and cooling trend requirements.
Various temperature monitors have been specifically made for monitoring pharmaceutical products. Some are simple data recorders that record a numeric temperature history over time. The data must be interpreted by a trained technician, and often requires an external computer to perform the analysis. Other devices provide alarms that are triggered if the temperature is out of an acceptable range, or out of range for a predetermined period of time. The alarm may not be produced if the temperature trends upward for less than the predetermined time, wherein such an upward trend is in violation of FDA regulations. An example of such a device is disclosed in U.S. Pat. No. 5,313,848 to Santin et al.